1. DMG Update UNOS Region 5 Collaborative
December 12, 2012
Darren Malinoski, MD
Megan Crutchfield, MPH
Section of Surgical Critical Care
Portland VA Medical Center

2. Questions to Run On
Do these data raise any questions or research ideas?
How will you use this information moving forward?
I would like to thank all of the members of the region 5 DMG workgroup and would be happy to entertain any questions.

3. The History of DMGs in Region 5
Phase 1 – retrospective – 10 DMGs
2007
Prior to recovery
320 donors
Phase 2 – prospective – 9 DMGs
July 2008 – July 2010
Three time points
914 donors
Phase 3 – prospective – modified the 9 DMGs
Aug 2010 – Feb 2012
Four time points
1684 donors
Phase 4 – The WEB PORTAL…

5. UNOS Region 5 DMG Web Portal Launched in March – supported by Tii
Linked to DonorNet
Forced field entry
Generates reports
Recipient data added by Tii
Fields for study data

6. Regional Update Phase 4 – THE WEB PORTAL Same DMGs as Phase 3
DMGs at four time points
Novel parameters: SVV/PPV/swan-ganz
Automatic calculations and forced field entries
BMI, donor hospital, registry, and research sections
Outcome data added daily
March 2012 through September 2012

7. Regional Update – Phase 4
807 donors (94% of donors in Unet)
534 SCD
181 ECD
92 DCD
3.23 OTPD (all donors)
SCD – 3.78
ECD – 2.35
DCD – 2.02

8. Phase 4 – organ utilization

9. The History of DMGs in Region 5
Phase 1 – retrospective – 10 DMGs
DMGs met in 30%
Phase 2 – prospective – 9 DMGs
DMGs met in 13%, 29%, and 34%
Phase 3 – prospective – modified DMGs
DMGs met in 9%, 21%, 48%, and 59%
Phase 4 – the WEB PORTAL…
DMGs met in 13%, 19%, 42%, and 60%*
*(DCDDs and DNDDs used in phase 4)

10. Web Portal Reports

11. Association between meeting the DMG Bundle and OTPD
OTPD WHEN DMGs NOT MET VS MET AT EACH TIME POINT
REFERRAL
AUTHORIZATION
12-18 HOURS
PRIOR TO OR
NOT MET
MET
Phase 1
---
3.34
4.35
Phase 2
3.28
3.92
3.10
3.99
3.02
4.04
Phase 3
3.38
3.35
3.25
3.80
2.87
3.87
2.53
3.88
Phase 4
3.22
3.83
3.13
2.42
Go to 2 decimal points for OTPD and no SD. Bold the ones that have a p <0.05
*(DCDDs and DNDDs used in phase 4), statistics not done yet

12. DMG web portal next steps
DMG Workgroup Considerations
Add pediatric DMGs
Modify existing DMGs
Glucose threshold
Add insulin dosages
Modify report format
Add other OPOs

13. Association between Different Glucose thresholds and OTPD
OTPD WHEN GLUCOSE LEVEL MET VS NOT MET AT EACH TIME POINT
REFERRAL
AUTHORIZATION
12-18 HOURS
PRIOR TO OR
OTPD p
< 150
3.41
0.989
3.45
0.236
3.47
0.450
0.200
> 150
3.35
3.42
3.39
< 180
0.162
0.449
3.44
0.737
3.48
0.015
> 180
3.34
3.29
< 200
3.46
0.102
0.410
0.259
0.006
> 200
3.32
3.40
3.38
3.21

14. Published/presented/ongoing research projects

15. HRSA Mild Hypothermia RCT
HRSA-funded multi-OPO randomized controlled trial
Intervention: Mild Hypothermia (34-35C) vs. Normothermia ( ) for > 12 hrs prior to organ recovery
Main outcome measures: DGF and SGF
Inclusion criteria: hemodynamically stable abdominal organ donors

16. HRSA Mild Hypothermia RCT
Enrolled 123 Donors since March 15th
4 hypothermic donors with adverse events
Hypokalemia <3.0 x 2
Arrhythmia – SVT and a.fib x 3
Afib – intermittent prior to BD, spontaneous conversion after K replaced (dropped to 2.9)
SVT – short run during prep in OR
Now replace K to 3.5 prior to enrollment and maintain
PEA arrest and rapid recovery of organs in Normothermia group
*No hemodynamic instability in Hypothermia group

17. HRSA Mild Hypothermia RCT
Challenges:
Determining when thoracic organs have been ruled out
Optimal notification of recipient centers
Next Steps:
Propose expansion to all research-authorized DNDDs – add thoracic donors
Trend towards increase in PaO2:FiO2 over time in hypothermia group (299 to 330, p=0.08)
22 Lungs and 12 Hearts

21. DMG/Variable OR (>4 OTPD) 95% CI p value
Continuous Variables
Age (years)
0.944
0.923 – 0.966
< 0.001
Creatinine (mg/dL)
0.636
0.409 – 0.987
0.044
Categorical Variables
Thyroid Hormone use
1.969
1.082 – 3.582
0.026
CVP 4 – 10 mmHg
1.897
1.021 – 3.527
0.043
EF > 50%
3.988
2.095 – 7.592
P:F > 300 on PEEP 5
4.591
2.478 – 8.506
Na 135 – 160 mEq/L
3.352
1.141 – 9.851
0.028
“Goals met”
4.394
2.497 – 7.732

23. - In press with the American Journal of Transplantation
Variable OR
95% CI p
Age (per year)
1.02
0.003
Creatinine prior to recovery (per mg/dL)
1.4
0.001
ECD
0.9
0.664
Cold ischemia time (per hour)
1.03
0.011
DMGs met at consent
0.5
0.019
- In press with the American Journal of Transplantation

24. Registered Organ Donors Receive Similar Levels of Intensive Care from Donor Hospitals Compared to Non-Registered Donors: An Opportunity to Increase Public Intent to Donate
Intent to donate affected by perception that patients with “pink dot” on license will receive less care from doctors
Objective: compare the rate of “meeting DMGs” between registered and non-registered donors

25. Not on State Registry (n=489)
Registered Organ Donors Receive Similar Levels of Intensive Care from Donor Hospitals Compared to Non-Registered Donors: An Opportunity to Increase Public Intent to Donate
[all donors included]
Not on State Registry (n=489)
On State Registry (n=144)
p value
DMGs met at referral 9%
0.846
DMGs met at consent
22%
20%
0.655
DMGs met hours
48%
52%
0.334
DMGs met prior to OR
58%
69%
0.019
OTPD
0.104
-presented at 2012 ATC

26. Conclusions
Patients who are registered to be organ donors and suffer devastating brain injuries appear to receive the same level of critical care support from their healthcare providers prior to their intent to donate being established as those who are not registered to be organ donors.
Registered donors are more likely to meet pre-determined critical care endpoints of resuscitation after consent for organ donation.

29. Variables Associated with Liver Graft Transplantation
Lower Age
Lower BMI
Male Gender
SCD status (vs. ECD)
Higher MAP
Lower CVP
Higher Ejection Fraction
Higher PaO2:FiO2
Lower Glucose
Vasopressin use
To summarize, variables seen to associate with graft transplantation are: the donor demographics of Lower Age and BMI, Male Gender and SCD status ;
And the critical care values of Higher MAP, Lower CVP, Higher Ejection Fraction; better oxygenation ratios; Lower Glucose; and the use of Vasopressin

30. Variables Associated with Liver Graft Discard
From 873 Procured livers…
730 Livers Transplanted,
143 Livers Discarded (16%)
We turned to look at associations with liver graft discards. These were organs which were procured, but ultimately not used for transplant, most likely upon inspection by the transplant surgeons. And of 873 livers, 730 were used

31. Variables Associated with Liver Graft Discard
Older Age
Higher BMI
Female Gender
ECD status (vs. SCD)
Higher CVP
Lower Urine Output
Lower PaO2:FiO2
Lower thyroid hormone dosages
The variables we found associated with graft discard were
The demographics of Older Age and higher BMI, Female Gender, Extended Criteria Donor status, Higher CVP, Lower Urine Output, worse pulmonary function, Lower doses of thyroid hormone

32. Variables Associated with Liver Graft Survival
730 Livers Transplanted
694 (95%) survival after 74±73 days
Finally we analyzed the livers were used for transplant, which were 730 in number. At a mean follow-up of 74 days ( and some had much longer follow up) 95% of grafts were still functioning.
These grafts were associated with the Donor demographics of lower age, lower BMI and SCD status. Gender was not important.
Variable
Graft Survival vs. Failure
Age (years)
38 vs. 44
BMI (kg/m2)
26 vs. 30
SCD
96% vs. 91%
Male Gender
96% vs. 94%

33. Variables Associated with Liver Graft Survival
Cold Ischemia Time did not differ
7.4 vs. 7.7 hours, p=0.675
None of the critical care endpoints or medications were associated with graft survival
In this analysis, the cold ischemia time did not differ between surviving and failing grafts.
But what was interesting was that none of the DMGs obtained, or medications used were associated with graft survival. Does that mean that nothing I do in the ICU can impact on graft survival? It is possible that the care provided across the board is becoming increasingly more uniform, and there were few donors with only very low numbers of critical care endpoints met. Its also likely that transplant surgeons are getting more experience at rejecting organs that are likely to fail, because the overall failure rate of 5% is low. I’d like to think that, The selection process may have already chosen for livers managed well, and so they went on to do well.
Clearly Important, recipient medical demographics and are not included in this analysis

34. Conclusions
Donor age, BMI, SCD status, and gender are associated with both liver graft transplantation and discard rates
Lower donor age, BMI, and SCD status are associated with graft survival rates
Among the fixed Donor characteristics, we found that Donor Age, BMI, SCD, and gender were associated with both graft utilization and graft discard rates
But among the organs then selected for transplant, only donor age, BMI, and SCD are associated with graft survival.

38. Questions to Run On
Do these data raise any questions or research ideas?
How will you use this information moving forward?
I would like to thank all of the members of the region 5 DMG workgroup and would be happy to entertain any questions.